Inhaled vs Intranasal Corticosteroids for Chronic Cough in Upper Airway Cough Syndrome

NCT07777796 | Completed

• 3 other identifiers: PCN/CBN/0052/KB1/73/22BNW-1-049/K/3/KBNW-1-169/K/4/K
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic cough - a cough lasting eight weeks or longer - is one of the most common reasons people see a lung specialist. It can disturb sleep, make conversation difficult, and reduce quality of life. In many people, chronic cough occurs together with nose and sinus symptoms such as a blocked or runny nose, mucus dripping down the back of the throat, facial pain, or a reduced sense of smell. This combination is often called upper airway cough syndrome. Doctors commonly treat it with a steroid medicine given either as an inhaler breathed into the lungs or as a spray into the nose. Both are approved, widely used medicines, and treatment guidelines mention both. However, no study has directly compared the two to see whether one relieves cough better than the other, so doctors have little evidence to guide the choice. This study compares the two treatments directly in adults who have chronic cough together with nose or sinus symptoms. Participants are assigned by chance, like flipping a coin, to one of two groups: an inhaled steroid (budesonide), breathed in twice a day, or a steroid nasal spray (mometasone furoate), sprayed into each nostril twice a day. Participants use their assigned treatment for 4 weeks and then return to the clinic. At each visit they rate how severe their cough is by marking a line on a 100-millimetre scale, and they fill in a questionnaire about how the cough affects their daily life. Participants whose cough has cleared up after 4 weeks finish the study at that point. Those whose cough has not cleared up continue for another 4 weeks: people in the inhaler group carry on with the same inhaler, while people in the nasal spray group continue the spray and also start the inhaler. Everyone who continues returns for a final visit at 8 weeks. The main question is whether the inhaled steroid reduces cough severity more than the nasal spray after 4 weeks of treatment. The study also looks at cough-related quality of life, and at what happens after treatment is adjusted at 4 weeks. The study takes place at a single outpatient lung clinic in Katowice, Poland. Both medicines are given at their usual approved doses, and participants are otherwise cared for as in routine practice.

Conditions

Chronic Cough (CC); Upper Airway Cough Syndrome; Chronic Rhinitis

Keywords

chronic cough; Upper airway cough syndrome; inhaled corticosteroids; intranasal corticosteroids

Outcome Measures

Primary Outcomes (1)

• Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 4 weeks

  Cough severity is self-rated by the participant on a 100-mm visual analog scale ranging from 0 mm ("no cough") to 100 mm ("worst cough"); higher scores indicate more severe cough. The 4-week score is compared between arms by analysis of covariance with the baseline VAS score as covariate, and reported as an adjusted between-group difference with a 95% confidence interval.

  Baseline and week 4

Secondary Outcomes (5)

• Change from baseline in cough severity measured by Visual Analog Scale (VAS) at 8 weeks

  Baseline and week 8

• Change from baseline in cough-related quality of life measured by Leicester Cough Questionnaire (LCQ) total score

  Baseline, 4 weeks and 8 weeks

• Proportion of participants achieving therapeutic success

  4 weeks and 8 weeks

• Proportion of participants achieving cough resolution

  4 weeks and 8 weeks

• Change from baseline in Leicester Cough Questionnaire (LCQ) domain scores

  Baseline, 4 weeks and 8 weeks

Study Arms (2)

Inhaled corticosteroids group

ACTIVE COMPARATOR

Participants receive inhaled budesonide 400 µg per dose, two doses twice daily (800 µg per administration; 1600 µg total daily), for 4 weeks. Cough severity is assessed at the 4-week visit. Participants reaching a Visual Analog Scale score of 10 mm or lower are classified as having achieved cough resolution and complete the study at this point. Participants not reaching this threshold continue inhaled budesonide unchanged at the same dose for a further 4 weeks, to a total of 8 weeks, with a final assessment at week 8.

Drug: Budesonide (400μg/d)

Intranasal(+inhaled) corticosteroids group

EXPERIMENTAL

Participants receive intranasal mometasone furoate 50 µg per dose, two doses into each nostril twice daily (100 µg per nostril per administration; 400 µg total daily), for 4 weeks. Cough severity is assessed at the 4-week visit. Participants reaching a Visual Analog Scale score of 10 mm or lower are classified as having achieved cough resolution and complete the study at this point. Participants not reaching this threshold continue intranasal mometasone furoate at the same dose with inhaled budesonide 400 µg per dose, two doses twice daily, added for a further 4 weeks, to a total of 8 weeks, with a final assessment at week 8. Beyond week 4 this arm therefore receives combined intranasal and inhaled corticosteroid therapy rather than intranasal monotherapy.

Drug: Budesonide (400μg/d); Drug: Mometasone Furoate 50mcg Nasal Spray

Interventions

Budesonide (400μg/d) DRUG

Inhaled budesonide 400 µg per dose, two doses twice daily (800 µg per administration; 1600 µg total daily), administered by inhaler. In the inhaled corticosteroid arm it is given from randomization as monotherapy for 4 weeks, and continued unchanged at the same dose for a further 4 weeks in participants who have not achieved cough resolution. In the intranasal corticosteroid arm it is added to ongoing intranasal mometasone furoate at week 4 in participants who have not achieved cough resolution, and given for 4 weeks. Maximum total duration of exposure is 8 weeks.

Inhaled corticosteroids group; Intranasal(+inhaled) corticosteroids group

Mometasone Furoate 50mcg Nasal Spray DRUG

Intranasal mometasone furoate 50 µg per dose, two doses into each nostril twice daily (100 µg per nostril per administration; 400 µg total daily), administered by nasal spray. Given from randomization for 4 weeks. Participants who have not achieved cough resolution at 4 weeks continue it at the same dose for a further 4 weeks with inhaled budesonide added. Maximum total duration of exposure is 8 weeks.

Intranasal(+inhaled) corticosteroids group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic cough and signs of chronic upper airway disease

You may not qualify if:

• Symptoms of an acute respiratory tract infection within 4 weeks prior to enrolment.
• Diagnosis of any active chronic respiratory disease.
• Diagnosis of other cause of chronic cough.
• Use of corticosteroids (oral, intranasal, inhaled, intravenous) within 3 months prior to enrolment.
• Chronic use of angiotensin-converting enzyme (ACE) inhibitors within 1 month prior to enrolment.
• Smoking of tobacco products within 6 months prior to enrolment
• Pregnancy.

Sponsors & Collaborators

• Silesian University of Medicine: lead

Study Sites (1)

Leszek Giec Upper-Silesian Medical Centre of the Medical University of Silesia

Katowice, Silesian Voivodeship, 40-635, Poland

Location

MeSH Terms

Conditions

Chronic Cough; upper airway cough syndrome

Interventions

Budesonide; Mometasone Furoate; Nasal Sprays

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: July 1, 2022
• Primary Completion: July 30, 2026
• Study Completion: July 30, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

PL (1)